The Psychoactive Trials Group at the Centre for Affective Disorders is undertaking controlled clinical trials with psychedelics and related compounds such as psilocybin, 5-MeO-DMT and MDMA. We are studying psychedelic therapies for different conditions including treatment-resistant depression and posttraumatic stress disorder. These trials are led by Dr James Rucker and Professor Allan Young.
The aim of these trials is to explore the safety and effectiveness of these therapies. In addition, we are investigating how these new approaches could be realised in healthcare systems, developing therapist training programs and training resources for wider implementation, if they are licensed.
At the Institute of Psychology, Psychiatry & Neuroscience, King’s College London, we are experts in this field. Our combination of specialist clinical teams, research infrastructure and a diverse partnership portfolio means we are well-equipped to test and develop novel therapeutics.
In 2022, together with South London and Maudsley NHS Foundation Trust and COMPASS Pathways, we launched the Centre for Mental Health Research and Innovation to accelerate psychedelic research.
The funding for our trials comes from a mixture of commercial and non-commercial funders.
If you’d like to apply for one of our ongoing trials please click on the following Project tab.
Projects

BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression
BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

COMP006 Study - COMP360 (psilocybin) for treatment resistant depression
A phase 3 trial investigating psilocybin therapy for treatment resistant depression

Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) Study
This is a phase 2, randomised, placebo-controlled trial investigating psilocybin therapy as a treatment for treatment resistant depression.
News
Largest trial to date shows that psilocybin reduces depression symptoms
A new multicentre clinical trial led by COMPASS Pathways across 22 international sites, including the Institute of Psychiatry, Psychology & Neuroscience...

New partnership launched with SLaM and COMPASS Pathways
The Institute for Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has announced a new partnership to launch The Centre for Mental...

Psilocybin, in 10mg or 25mg doses, has no short- or long-term detrimental effects in healthy people
Psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

Background
History of human use of psychedelics
In the past, psychedelics like psilocybin, mescaline and ayahuasca have been used by different cultures around the world in ceremonial, spiritual and ‘healing’ rituals. Some continue to be used legally by the descendants of those indigenous cultures. Such rituals come with a rich and important history that inform about their role and use.
History of psychedelics in psychiatry
Prior to 1970 the classical psychedelics psilocybin, mescaline and d-lysergic acid diethylamide (LSD) were used in psychiatry as part of an ongoing process of psychotherapy for resistant forms of depression, anxiety and addictions. Research at that time, which was suboptimal by modern standards, suggested that they were helpful for some people when given within a medically controlled and psychologically supportive context.

After 1970, LSD, psilocybin and mescaline were legally designated ‘Schedule 1’ substances, meaning that they could not be prescribed by medical doctors outside of authorised research. Funding for research dried up in the wake of hardening socio-political attitudes towards psychoactive drugs in general. Consequently, this area of clinical research stopped without a clear view about whether psychedelic therapy was safe and effective.
Since 2000, there has been a slow but steady resurgence of clinical research interest into psychedelics and related compounds such as MDMA and ketamine. A growing number of clinical trials have been published. Here at KCL, we are part of this research.
The need for new paradigms of treatment in psychiatry
Whilst many patients with mental health problems get better with available treatments, a subgroup of people do not even though they try many different forms of treatment. This is sometimes called ‘treatment resistance’. This can lead to a variety of other problems that seriously impact on patients and the people around them. Treatment options are often limited and come with troublesome side effects or stigma. Therefore, new paradigms of treatment are needed and clinical research of new treatments is important. Psychedelic therapy may be a new paradigm of treatment, but this needs to be tested in clinical trials.
Oversight of our trials
All of our clinical trials are authorised by the National Research Ethics Committee, who are a group of professionals and members of the public whose job is to scrutinise and ensure the rights and wellbeing of participants in clinical trials. All of our clinical trials are registered with the Medicine’s and Healthcare Products Regulatory Agency, who are a government funded body whose job is to ensure that treatment development and research is being conducted according to internationally agreed standards with interventions manufactured to proper standards. All of our trials are regularly reviewed by the Sponsors and the Ethics Committees, who are able to halt a trial if they think it is no longer appropriate for it to continue.
Completed Trials
The effects of psilocybin on cognitive function in healthy participants
In partnership with COMPASS Pathways researchers from King’s College London have established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.
The trial is now finished and results were published in The Journal of Psychopharmacology in March 2022. They represent an essential first step in demonstrating the safety and feasibility of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Healthy participants |
Intervention |
Psilocybin |
Recruitment period |
2018-2020 |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |
The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD) Study
King’s College London were part of a multi-centre trial led by COMPASS Pathways that is called P-TRD. The trial was conducted across 22 sites in 10 countries from Europe and the US. Adults with treatment resistant depression were given psilocybin at a dose of 25 mg, 10 mg, or 1 mg. The drug was administered together with psychological support and researchers measured changes in depression symptoms.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Treatment resistant depression |
Intervention |
Psilocybin therapy |
Recruitment period |
2020-2021 |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |
An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3 [2 (dimethylamino)ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL PSILO) on Cognition in Patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) are debilitating and there are few treatment options. With funding from Beckley PsyTech researchers from King’s investigated the efficacy of psilocybin at three doses for treating these headache attacks, particularly looking at its impact on thought processes.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
SUNHA |
Intervention |
3 doses of psilocybin |
Recruitment period |
2022 |
Funder |
Beckley PsyTech |
Sponsor |
Beckley PsyTech |
A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects
In partnership with Beckley PsyTech, King’s researchers evaluated the safety and tolerability of the psychedelic 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) which is found in a variety of plant species and secreted by one species of toad. It was administered nasally to healthy participants at one dosage and researchers assessed the percentage of participants that experienced any unfavourable and unintended signs, alongside various measures to assess what is happening to the drug when it is taken.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Healthy participants |
Intervention |
5-Methoxy-N,N-Dimethyltryptamine |
Recruitment period |
2021 – 2022 |
Funder |
Beckley PsyTech |
Sponsor |
Beckley PsyTech |
Publications:
https://journals.sagepub.com/doi/full/10.1177/02698811211064720
An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA- Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder
With support from the Multidisciplinary Association of Psychedelic Studies (MAPS) we trialled MDMA therapy for PTSD for veterans.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
PTSD |
Intervention |
MDMA |
Recruitment period |
2022 – 2023 |
Funder |
MAPS |
Sponsor |
MAPS |
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
With support from Compass Pathways, we explored the safety and tolerability of of COMP360 (psilocybin) given alongside psychological support to participants suffering from post-traumatic stress disorder. This trial was undertaken alongside colleagues in the United States.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
PTSD |
Intervention |
Psilocybin |
Recruitment period |
2022 – 2023 |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |
An Open-Label, Phase 2a Single Dose Study of 5-MeO-DMT in Patients With Alcohol Use Disorder
With the support of Beckley PsyTech we trialled 5-MeO-DMT given with structured psychological support for alcohol use disorder. 5-MeO-DMT is a short-acting psychedelic drug, which means that it induces an altered state of consciousness that can be characterised by mystical experiences, strong emotions, visions and distorted perceptions.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Alcohol use disorder |
Intervention |
5-MeO-DMT with Structured Psychological Support |
Recruitment period |
2023-24 |
Contact |
|
Funder |
Beckley PsyTech |
Sponsor |
Beckley PsyTech |
With support from Transcend Therapeutics, we explored the safety and efficacy of methylone treatment in patients suffering from post-traumatic stress disorder.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Post-traumatic stress disorder |
Intervention |
Methylone therapy |
Recruitment period |
2024 |
Contact |
|
Funder |
Transcend Therapeutics |
Sponsor |
Transcend Therapeutics |
Projects

BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression
BPL-003-201 Study - 5-MeO-DMT Therapy for Treatment Resistant Depression

COMP006 Study - COMP360 (psilocybin) for treatment resistant depression
A phase 3 trial investigating psilocybin therapy for treatment resistant depression

Psilocybin in Depression Resistant to Standard Treatments (PsiDeR) Study
This is a phase 2, randomised, placebo-controlled trial investigating psilocybin therapy as a treatment for treatment resistant depression.
News
Largest trial to date shows that psilocybin reduces depression symptoms
A new multicentre clinical trial led by COMPASS Pathways across 22 international sites, including the Institute of Psychiatry, Psychology & Neuroscience...

New partnership launched with SLaM and COMPASS Pathways
The Institute for Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has announced a new partnership to launch The Centre for Mental...

Psilocybin, in 10mg or 25mg doses, has no short- or long-term detrimental effects in healthy people
Psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

Background
History of human use of psychedelics
In the past, psychedelics like psilocybin, mescaline and ayahuasca have been used by different cultures around the world in ceremonial, spiritual and ‘healing’ rituals. Some continue to be used legally by the descendants of those indigenous cultures. Such rituals come with a rich and important history that inform about their role and use.
History of psychedelics in psychiatry
Prior to 1970 the classical psychedelics psilocybin, mescaline and d-lysergic acid diethylamide (LSD) were used in psychiatry as part of an ongoing process of psychotherapy for resistant forms of depression, anxiety and addictions. Research at that time, which was suboptimal by modern standards, suggested that they were helpful for some people when given within a medically controlled and psychologically supportive context.

After 1970, LSD, psilocybin and mescaline were legally designated ‘Schedule 1’ substances, meaning that they could not be prescribed by medical doctors outside of authorised research. Funding for research dried up in the wake of hardening socio-political attitudes towards psychoactive drugs in general. Consequently, this area of clinical research stopped without a clear view about whether psychedelic therapy was safe and effective.
Since 2000, there has been a slow but steady resurgence of clinical research interest into psychedelics and related compounds such as MDMA and ketamine. A growing number of clinical trials have been published. Here at KCL, we are part of this research.
The need for new paradigms of treatment in psychiatry
Whilst many patients with mental health problems get better with available treatments, a subgroup of people do not even though they try many different forms of treatment. This is sometimes called ‘treatment resistance’. This can lead to a variety of other problems that seriously impact on patients and the people around them. Treatment options are often limited and come with troublesome side effects or stigma. Therefore, new paradigms of treatment are needed and clinical research of new treatments is important. Psychedelic therapy may be a new paradigm of treatment, but this needs to be tested in clinical trials.
Oversight of our trials
All of our clinical trials are authorised by the National Research Ethics Committee, who are a group of professionals and members of the public whose job is to scrutinise and ensure the rights and wellbeing of participants in clinical trials. All of our clinical trials are registered with the Medicine’s and Healthcare Products Regulatory Agency, who are a government funded body whose job is to ensure that treatment development and research is being conducted according to internationally agreed standards with interventions manufactured to proper standards. All of our trials are regularly reviewed by the Sponsors and the Ethics Committees, who are able to halt a trial if they think it is no longer appropriate for it to continue.
Completed Trials
The effects of psilocybin on cognitive function in healthy participants
In partnership with COMPASS Pathways researchers from King’s College London have established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.
The trial is now finished and results were published in The Journal of Psychopharmacology in March 2022. They represent an essential first step in demonstrating the safety and feasibility of psilocybin for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Healthy participants |
Intervention |
Psilocybin |
Recruitment period |
2018-2020 |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |
The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (P-TRD) Study
King’s College London were part of a multi-centre trial led by COMPASS Pathways that is called P-TRD. The trial was conducted across 22 sites in 10 countries from Europe and the US. Adults with treatment resistant depression were given psilocybin at a dose of 25 mg, 10 mg, or 1 mg. The drug was administered together with psychological support and researchers measured changes in depression symptoms.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Treatment resistant depression |
Intervention |
Psilocybin therapy |
Recruitment period |
2020-2021 |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |
An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3 [2 (dimethylamino)ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL PSILO) on Cognition in Patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) are debilitating and there are few treatment options. With funding from Beckley PsyTech researchers from King’s investigated the efficacy of psilocybin at three doses for treating these headache attacks, particularly looking at its impact on thought processes.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
SUNHA |
Intervention |
3 doses of psilocybin |
Recruitment period |
2022 |
Funder |
Beckley PsyTech |
Sponsor |
Beckley PsyTech |
A Double-Blind, Randomized, Phase 1, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Intranasal 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) in Healthy Subjects
In partnership with Beckley PsyTech, King’s researchers evaluated the safety and tolerability of the psychedelic 5 Methoxy N,N-dimethyltryptamine (5-MeO-DMT) which is found in a variety of plant species and secreted by one species of toad. It was administered nasally to healthy participants at one dosage and researchers assessed the percentage of participants that experienced any unfavourable and unintended signs, alongside various measures to assess what is happening to the drug when it is taken.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Healthy participants |
Intervention |
5-Methoxy-N,N-Dimethyltryptamine |
Recruitment period |
2021 – 2022 |
Funder |
Beckley PsyTech |
Sponsor |
Beckley PsyTech |
Publications:
https://journals.sagepub.com/doi/full/10.1177/02698811211064720
An Open-Label, Phase 2, Multicenter Feasibility Study of Manualized MDMA- Assisted Psychotherapy with an Optional fMRI Sub-Study Assessing Changes in Brain Activity in Subjects with Posttraumatic Stress Disorder
With support from the Multidisciplinary Association of Psychedelic Studies (MAPS) we trialled MDMA therapy for PTSD for veterans.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
PTSD |
Intervention |
MDMA |
Recruitment period |
2022 – 2023 |
Funder |
MAPS |
Sponsor |
MAPS |
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
With support from Compass Pathways, we explored the safety and tolerability of of COMP360 (psilocybin) given alongside psychological support to participants suffering from post-traumatic stress disorder. This trial was undertaken alongside colleagues in the United States.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
PTSD |
Intervention |
Psilocybin |
Recruitment period |
2022 – 2023 |
Funder |
Compass Pathways |
Sponsor |
Compass Pathways |
An Open-Label, Phase 2a Single Dose Study of 5-MeO-DMT in Patients With Alcohol Use Disorder
With the support of Beckley PsyTech we trialled 5-MeO-DMT given with structured psychological support for alcohol use disorder. 5-MeO-DMT is a short-acting psychedelic drug, which means that it induces an altered state of consciousness that can be characterised by mystical experiences, strong emotions, visions and distorted perceptions.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Alcohol use disorder |
Intervention |
5-MeO-DMT with Structured Psychological Support |
Recruitment period |
2023-24 |
Contact |
|
Funder |
Beckley PsyTech |
Sponsor |
Beckley PsyTech |
With support from Transcend Therapeutics, we explored the safety and efficacy of methylone treatment in patients suffering from post-traumatic stress disorder.
Status |
Completed, not recruiting |
Participants |
Adults |
Clinical area |
Post-traumatic stress disorder |
Intervention |
Methylone therapy |
Recruitment period |
2024 |
Contact |
|
Funder |
Transcend Therapeutics |
Sponsor |
Transcend Therapeutics |